MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK PROTECT- zinc oxide liquid

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS
Active Ingredient

Zinc Oxide 20.0%
Purpose

Sunscreen
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- SHAKE WELL BEFORE USE.
- For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
- Apply liberally and evenly 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  - Limit time in the sun, especially from 10 a.m. – 2 p.m.
  - Wear long-sleeve shirts, pants, hats and sunglasses.
  - Children under 6 months: Ask a doctor.
Inactive Ingredients

Agave Tequilana Leaf Extract, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate, Ethyl Ferulate, Glycerin, Hydrolyzed Wheat Protein / PVPCrosspolymer,Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, Water
Other Information
- Protect this product from excessive heat and direct sun.
- May stain some fabrics.
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Liquid SPF 50
Medium/Dark

Broad-spectrum
Protection, Bentonite
Clay & Safflower
Smooth & Balance

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

SAME FORMULA
NEW
NAME

1.0 fl oz/30 mL

MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK PROTECT
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)
Bentonite (UNII: A3N5ZCN45C)
LEVOMENOL (UNII: 24WE03BX2T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Caprylhydroxamic Acid (UNII: UPY805K99W)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
Caprylyl Glycol (UNII: 00YIU5438U)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
Diheptyl Succinate (UNII: 057N7SS26Y)
Ethyl Ferulate (UNII: 5B8915UELW)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)
Octyldodecanol (UNII: 461N1O614Y)
Sodium Gluconate (UNII: R6Q3791S76)
TOCOPHEROL (UNII: R0ZB2556P8)
Trihydroxystearin (UNII: 06YD7896S3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72805-200-30	1 in 1 BOX	04/01/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/01/2021

Labeler - French Transit, Ltd. (100044380)

MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK PROTECT- zinc oxide liquid

MyChelle Dermaceuticals Sun Shield SPF 50 Medium/Dark by

Drug Labeling and Warnings

Drug Details [pdf]